Sponsor study identifier
observational
220
1 country
5
Study Start
March 5, 2024
Actual (reported)Primary Completion
August 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2024
Actual (reported)March 5, 2024
Actual (reported)March 20, 2024
Actual (reported)August 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Implant Survivorship
Implant survivorship at 2 years post operatively defined as absence of device removal or revision of any component
2 years
Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years
6 months, 1 year, 3.5 years, and 5 years
Radiographic Assessment - Glenoid Migration/Subsidence
Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Glenoid Radiolucency
Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Radiolucency
Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Migration/Subsidence
Day 0, 1 year, 2 years, and 5 years
Those subjects who have the AETOS implanted in the Primary Anatomic configuration
Those subjects who have AETOS implanted in the Reverse configuration
The AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Males and females who are at least 18 years of age at the time of consent, are skeletally mature, and are indicated for primary anatomic or primary reverse will be enrolled in the study
California Pacific Orthopedics
San Francisco, California, 94118, United States
Western Orthopaedics
Denver, Colorado, 80210, United States
Kolja Boese
Smith & Nephew, Inc.
First Submitted
February 28, 2024
First Posted
March 20, 2024
Study Start
March 5, 2024
Actual (reported)Primary Completion
August 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement
Contact the study team to confirm eligibility.
Hughston Foundation
Columbus, Georgia, 31909, United States
Center for Orthopedics and Neurosurgical Care
Bend, Oregon, 97701, United States
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Study Completion
August 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 7, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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